← Back to catalogue
Gutta Percha Points
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 158-S614Model GUTTA PERCHA POINTS DIA-PROISO.04 #80
Identity
- Trade Name
- GUTTA PERCHA POINTS EUDAMEDFDA UDI
- Generic Name
- Natural gutta-percha FDA UDI
- Device Name
- GUTTA PERCHA POINTS EUDAMEDGutta Percha Points is used to root canal filing material. FDA UDI
- Model / Reference
- GUTTA PERCHA POINTS DIA-PROISO.04 #80 EUDAMED158-S614 EUDAMED.04 TAPER 80 FDA UDI
- Description
- Gutta Percha Points is used to root canal filing material. FDA UDI
Identifiers
- Catalog Number
- 158-S614 FDA UDI
- Primary DI / UDI-DI
- 08806383568043 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08806383568043 EUDAMED
- FDA Product Code
- EKM FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
- GMDN Term
- Natural gutta-percha FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3850 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Natural gutta-percha
Gutta Percha Points by DiaDent Group International — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Natural gutta-percha.
- SSW ENDO — SS White Burs LLC · Class I
- DCTAPER — SS White Burs LLC · Class I
- Top Quality Manufacturing — TOP QUALITY MANUFACTURING, INC. · Class I
- GuttaCore Obturator — TULSA DENTAL PRODUCTS LLC · Class I
- Patterson — PATTERSON DENTAL SUPPLY, INC. · Class I
- DCTAPER — SS White Burs LLC · Class I
- EndoREZ Points — ULTRADENT PRODUCTS, INC. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DiaDent Group International
Sources (2)
- FDA UDI 0bc054f4-ce01-4fc5-a732-de90503fe86c 35 fields · synced Oct 6, 2026
- EUDAMED 0dd1b366-0fe3-4491-83e7-d62c33c7cfc6 61 fields · synced Oct 6, 2026